QA Compliance Program Specialist III

Reporting to the QA Compliance Program Supervisor, the QA Compliance Specialist III focuses on facilitating Compliance and CAPA System activities at American Regent. This is a multi-disciplinary role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at all American Regent Sites in Ohio.

Responsibilities

• Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines.
• Facilitate, maintain, and improve the Internal Audit Program. Work with Functional Area Management and cross-functional teams to ensure procedural compliance and alignment with internal, regulatory, and corporate requirements.
• Facilitate, maintain, and improve the Compliance Corrective Action and Preventive Action (CAPA) System. Work with owners and cross-functional teams to ensure appropriate Corrective Action Plans are implemented and verified for effectiveness in accordance with company SOPs, policies, and cGMPs, and escalate when necessary.
• Drive development and maintenance of the Customer Complaints Program in Ohio, including metric reporting. Work with functional areas to investigate and ensure timely closure of Customer Complaints.
• Facilitate, maintain, and improve the Gap Assessment program, ensuring procedural compliance and alignment with regulatory (domestic and foreign) compendia, and corporate requirements.
• Facilitate, maintain, and improve the inspection readiness program, including participation in the ‘tactical room’ for regulatory and customer audits.
• Facilitate and support the Field Alert Report Program in Ohio, including metric reporting. Work with functional areas to investigate and ensure timely closure of potential Field Alert Reports (pFARs) and FARs.
• Facilitate and support all follow-up actions related to customer audits, corporate audits, and regulatory inspections, and confirm appropriateness and measure effectiveness of associated CAPA.
• Continually improve, maintain, and present Quality Systems reports/metrics to Senior Management.
• Facilitate and support the Risk Management program.
• Facilitate and support Continuous Improvement portfolio activities as it relates to Compliance. This may involve cross-functionality of areas from QA, QC, OPS, and may require statistical concepts and methodologies.
• Mentor Compliance Staff across multiple areas.
• Perform any other tasks/duties as assigned by management.

Requirements

• Bachelor’s in Life Science, Statistics, related field, or equivalent years of experience required.
• Minimum of 5 years of work experience in QA, Regulatory Compliance, or Pharmaceutical Operations in a cGMP manufacturing environment is required.
• Experience across multiple areas including developing quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities, validation for pharmaceutical manufacturing facilities; review and release of cGMP production batches.
• Knowledge of US regulations and experience in interpreting and applying them to the organization is required.
• Knowledge of international regulations and experience in interpreting and applying them to the organization is preferred.
• General knowledge of overall statistical concepts and Green Belt Six Sigma certification is preferred.